Synthes recalls Universal Chuck instrument handles used in orthopedic surgery due to risk of top cap detaching if jammed, causing surgical delays or infection.
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Synthes is recalling Universal Chuck instrument handles used in orthopedic surgery. If the device jams and the user tries to free it, the top cap may loosen and detach, potentially causing surgical delays or infections.
If the Universal Chuck becomes jammed during surgery and the user manually tries to free it, the top cap may loosen and detach. This can cause internal ball bearings to fall onto the surgical field, leading to surgical delays or potential infections if not properly cleaned.
Orthopedic surgeons and surgical teams using the Universal Chuck instrument handles for procedures like tibial nailing or femoral nailing. Those with the specific product numbers listed are most at risk.
Check for product numbers: 03.043.001; lots/serials: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201, 21869701, 21983904, 21995301. The Universal Chuck is used with specific orthopedic systems like TN-ADVANCED Tibial Nailing System.
Verify your Universal Chuck has product number 03.043.001 and one of the listed lot/serial numbers.
The Universal Chuck is an instrument handle used as an alternative for orthopedic surgery procedures like tibial nailing and femoral nailing.
If the top cap detaches, internal ball bearings may fall onto the surgical field, causing surgical delays or potential infections if not properly cleaned.
The recall record does not specify a remedy, so no action is required beyond checking if the product is affected.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0634-2022 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0634-2022 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
